Bringing new drugs to patients is an incredibly difficult task that involves numerous indispensable actors – from pioneering entrepreneurs and CEOs, to industry experts, to dedicated researchers, to regulators who keep everyone on the right tracks.

A View From the Biosynthetic Bridge

Regulations in the US make cannabis research highly challenging. Could biosynthetic approaches to cannabinoid production prompt regulators to rethink?

Jeff Korentur
|
06/21/2017

From a US perspective, cannabinoid-based drug development and research has been particularly difficult because of the designation of the plant. Cannabis, including its cannabinoids, are classified as “Schedule I” drugs, which means they are defined as having “a high potential for abuse,” “no currently accepted medical use in treatment in the United States,” and lacking “accepted safety for use [...] under medical supervision.” Researchers, therefore, need to jump through a number of regulatory hoops to carry out cannabinoid research. It’s interesting to contrast the US situation with what goes on in other countries, specifically in Israel, Canada and the UK, which is where most of the breakthroughs are taking place.

In the US, a few states have reclassified and legalized cannabis. For example, Colorado, legalized the recreational use of cannabis in 2012 for individuals over the age of 21. A number of Colorado residents suffering from certain medical conditions can also access cannabis from dispensaries that offer a range of cannabis strains with different qualities. In states where cannabis is legal, it is easier to conduct research, but there are limits. When Teewinot Life Sciences first started, we decided to focus on the biosynthetic production of pharma-grade cannabinoids but it was clear that we would quickly exceed what was legal in Colorado and elsewhere in the US. Today, we are headquartered in Tampa, Florida (which implemented the Florida Medical Marijuana Legalization Initiative in 2016). We conduct our internal research and development in Canada under license from Health Canada, and all our existing and planned intellectual property are housed by our subsidiary in Ireland. In fact, a number of US companies have uprooted and moved overseas to facilitate their cannabinoid research efforts.

Enjoy our FREE content!

Log in or register to read this article in full and gain access to
The Medicine Maker’s entire content archive. It’s FREE and always will be!